WASHINGTON, DC - On Wednesday, November 27th, H.R. 3204, the Drug
Quality and Security Act, was signed into law by President Obama.
Under the new law, the FDA will gain oversight of certain entities that
prepare compounded drugs, which will register with the FDA as "outsourcing
facilities.” These facilities will be subject to FDA inspection on a risk-based
schedule, as well as federal requirements for current good manufacturing
practice and other requirements. Drugs
that are produced by compounders that do not register as outsourcing facilities
must meet additional conditions described in the law, or face FDA regulation as
conventional drug manufacturers. This part of the law emerges in response to
the recent and devastating nationwide meningitis outbreak.
State boards of pharmacy will continue to have primary responsibility
for the day-to-day oversight of state licensed pharmacies, including
traditional pharmacy compounding.
The second part of the Drug Quality and Security Act will strengthen the
prescription drug supply chain of certain drugs to protect the public from
counterfeit, stolen, or otherwise harmful drugs. Manufacturers, repackagers,
wholesale drug distributers, and dispensers other than most licensed health
care practitioners will be required to provide product and transaction
information from each sale and notify the FDA and other stakeholders of
additional information, please visit: http://energycommerce.house.gov/fact-sheet/hr-3204-drug-quality-and-security-act